Improving Infant Sleep Safety With the Electronic Health Record

Not Applicable

Completed

• Conditions: Infant Development; SIDS
• Interventions: Behavioral: Safe

• Registration Number: NCT03662048
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

This research is being done to find out if individualized feedback provided to parents on safe infant sleep can improve safety. This will be accomplished by having parents send photographs of their baby sleeping through the patient portal of the electronic health record (EHR).

Detailed Description

The purpose of this study is to assess if photographs of infants sleeping at night sent by parents through the patient portal of the electronic health record (EHR) can be used to a) deliver individualized feedback on safe infant sleep surfaces and sleep health and b) improve parental knowledge of and adherence to guidelines for safe infant sleep surfaces and sleep health. The feasibility of this approach will also be assessed through a randomized, clinical trial involving 130 infants with primary care through Penn State Health. Participants will be randomized to receive personalized feedback on the infant sleep position and surface at age 1 month in addition to usual care or a usual care group. Both groups will receive personalized feedback on the infant sleep position and surface at infant age 2 months.

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-10-30
• Primary Completion: 2019-09-11
• Study Completion: 2019-09-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Gestational age: ≥37 weeks
• Singleton birth
• Newborns ages 0 days to 14 days old
• Newborn nursery stay <=7 days
• English speaking mother
• Mother ≥18 years old
• Has email/internet access
• Willing to sign up for the Penn State Health Patient Portal through the Electronic Health Record (EHR)
• Owns a smart phone, digital camera, or tablet that can take pictures to be transmitted through the EHR
• Plan to follow with a Penn State Health Provider though the infant's 3-4 month well child visit

Exclusion Criteria

• Maternal morbidity or pre-existing condition that affects ability to care for the newborn (e.g. narcotic drug use, chemotherapy, uncontrolled depression etc.)
• Child is being adopted or will not be in the care of the mother

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care	Safe	Parents will send the study team photographs of their infant sleeping during the night only at at age 2 months.
intervention at 1 month + usual care	Safe	Parents will send the study team photographs of their infant sleeping during the night at ages 1 and 2 months.

Primary Outcome Measures

Name	Time	Method
percentage of infants who do not meet all AAP recommendations for sleeping environments at age 2 months	2 months of age	Safe sleep environment will include: 1. Solitary vs. non-solitary sleep; 2. Supine vs. non-supine infant sleep position; 3. No loose objects vs. loose objects on the sleep surface; 4. Tight-bedding vs. loose-bedding; 5. Firm vs. soft sleep surface (i.e. crib/bassinete vs. sofa/bouncy chair); 6. Infant's sleeping in same room as parents vs. separate room; 7. No head coverings vs. head coverings

Secondary Outcome Measures

Name	Time	Method
Parent compliance	1 and 2 months of age	Proportion of parents that send photographs of their infant's sleep environment at ages 1 month (intervention group) and 2 months (both groups)

Trial Locations

Locations (1)

Penn State Milton S Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States